Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00858468 |
Primary Objectives:
Condition | Intervention | Phase |
---|---|---|
Influenza |
Biological: Influenza virus vaccine (2004-2005 Formulation) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Proof of Concept Study of the Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005 Among Healthy Children 2 Months vs 6 Months of Age |
Enrollment: | 394 |
Study Start Date: | April 2005 |
Study Completion Date: | December 2006 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Age 6 to 12 Weeks: Experimental
Participants aged 6 to 12 Weeks at enrollment
|
Biological: Influenza virus vaccine (2004-2005 Formulation)
0.25 mL, Intramuscular
|
Age 24 to 36 Weeks: Experimental
Participants aged 24 to 36 Weeks at enrollment
|
Biological: Influenza virus vaccine (2004-2005 Formulation)
0.25 mL, Intramuscular
|
This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested.
Ages Eligible for Study: | 2 Months to 9 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
United States, Arkansas | |
Little Rock, Arkansas, United States, 72205 | |
United States, Georgia | |
Marietta, Georgia, United States, 30062 | |
United States, North Carolina | |
Durham, North Carolina, United States, 27705 | |
United States, Ohio | |
Akron, Ohio, United States, 44308 | |
Dayton, Ohio, United States, 45404 | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States, 15241 | |
United States, Washington | |
Seattle, Washington, United States, 98101 |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur Inc. ( Medical Monitor ) |
Study ID Numbers: | GRC27 |
Study First Received: | March 5, 2009 |
Last Updated: | March 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00858468 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Influenza Influenza vaccine |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Healthy Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |